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Study of Effects of Sutures on Results of Palate Surgery for Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00205543
First received: September 15, 2005
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

In this study we will examine whether suture repair of the palate, or roof of mouth, has any effect on results of palate surgery performed for treatment of obstructive sleep apnea.


Condition Intervention
Obstructive Sleep Apnea
Procedure: uvulopalatopharyngoplasty with or without sutures

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role of Suture Closure in Post-Operative Uvulopalatopharyngoplasty Outcomes

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • sleep study result at 3-6 months; symptom changes at 3-6 months; pain at 0-3 weeks; post-operative complications at any time; post-operative anatomic result/appearance at 3-6 months [ Time Frame: 6-12mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Operative time [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • Procedure cost [ Time Frame: immediate ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: July 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
suture palate after resection
Procedure: uvulopalatopharyngoplasty with or without sutures
standard UPPP
Experimental: 2
suture one side of palate afer resection
Procedure: uvulopalatopharyngoplasty with or without sutures
standard UPPP
Experimental: 3
no sutures in palate after resection
Procedure: uvulopalatopharyngoplasty with or without sutures
standard UPPP

Detailed Description:

Uvulopalatopharyngoplasty, or UPPP, is the most common surgical procedure performed for the treatment of obstructive sleep apnea. The procedure involves removal of redundant tissue from the lower palate (roof of mouth), including the uvula, and then suturing the cut edges of the remaining tissue together. However it is frequently noted by surgeons that sutures placed in the roof of the mouth do not stay intact. Also, in standard tonsillectomy, which involves removal of the tonsils and thus creation of a wound near the palate, no suturing is used, which does not seem to affect how the area heals. Previous studies have shown no significant differences in complication rates, post-operative pain, or symptom outcomes in patients undergoing tonsillectomy either with or without suture repair of the tonsillectomy wound. In this study we will examine whether suture repair following UPPP has any effect on post-operative pain, healing, or treatment success in terms of symptom resolution or post-operative sleep study results.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • sleep-study documented obstructive sleep apnea
  • sleep apnea refractory to non-surgical treatments including continuous positive airway pressure (CPAP)
  • age > 21

Exclusion Criteria:

  • previous palate surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205543

Locations
United States, Virginia
Department of Otolaryngology - Head & Neck Surgery, Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0146
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Evan R Reiter, MD Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00205543     History of Changes
Other Study ID Numbers: 03802
Study First Received: September 15, 2005
Last Updated: June 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Virginia Commonwealth University:
obstructive sleep apnea
airway obstruction
sleep-disordered breathing

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 19, 2014